- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00554476
Comparison of Two Combined Therapeutic Methods for Treatment of Lateral Epicondylitis
Comparison of Two Combined Therapeutic Methods for Treatment of Lateral Epicondylitis: A Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Design: Randomized clinical trial. Setting: Boo-Ali and Baqyiatallah Hospital in Tehran. Patients: 50 randomly selected patients, in two groups of 25 subjects. Interventions: Corticosteroid injections with elbow cast versus icing and NSAIDs.
Outcome measures: Patients were evaluated for outcomes, complications and patients' satisfaction at 2nd, 4th, and 12th week after beginning of treatment. We measured the pain severity by Visual Analogue Scale (VAS).
Study Type
Enrollment
Phase
- Phase 4
Contacts and Locations
Study Locations
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Tehran, Iran, Islamic Republic of, 13456/7889
- Azad University of Medical Sciences, Boo-Ali Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- pain at the lateral side of the elbow
- pain at the lateral epicondyle during resisted dorsiflexion of the wrist with the elbow in full extension, or resisted extension of middle finger at the metacarpophalangeal joint
- pain to be continued for longer than 6 weeks or even with recurrent pain during similar period
Exclusion Criteria:
- previous history of receiving any treatment for lateral epicondylitis within 6 months prior to intervention
- patients who were unable to return for follow up
- patients with nerve entrapment
- pregnancy
- breast-feeding
- presence of systemic neuromuscular disorders such as myasthenia gravis
- upper limb fractures
- other arm/forearm pathology such as radial nerve compression
- known thrombocytopenia
- coagulopathy or bleeding diathesis
- history of diffuse pain syndrome
- history of inflammatory arthropathy
- intolerance/allergy to corticosteroids or NSAIDs or any contraindication for these
- untreated depression
- history of narcotic use for pain management greater than 1 month or history of narcotic abuse problem
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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visual analogue scale (VAS)
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Secondary Outcome Measures
Outcome Measure |
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Patient's satisfaction
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Collaborators and Investigators
Investigators
- Principal Investigator: Jaleh Hassanloo, MD, Department of Orthopedics, Boo-Ali Hospital
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Wounds and Injuries
- Musculoskeletal Diseases
- Muscular Diseases
- Tendon Injuries
- Tendinopathy
- Arm Injuries
- Elbow Tendinopathy
- Tennis Elbow
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Immunosuppressive Agents
- Immunologic Factors
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Reproductive Control Agents
- Gout Suppressants
- Tocolytic Agents
- Triamcinolone
- Triamcinolone Acetonide
- Triamcinolone hexacetonide
- Triamcinolone diacetate
- Indomethacin
Other Study ID Numbers
- RCT-246910-06
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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